RANBAXY

PATIENT INFORMATION LEAFLET

MECYSTEINE HYDROCHLORIDE 100 mg GASTRO-RESISTANT TABLETS

In this leaflet:

1.    What Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets are and what they are used for

2.    Before you take Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets

3.    How to take Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets

4.    Possible side effects

5.    Storing Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets

The name of your medicine is Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets and contain 100 mg of mecysteine hydrochloride.

Your tablets also contain the following inactive ingredients: anhydrous lactose anhydrous, povidone, magnesium stearate, heavy kaolin, stearic acid, polyvinylacetate phthalate, acacia, gelatin, sucrose, calcium carbonate, talc, hydrated aluminium oxide, titanium dioxide (E171), quinoline yellow (E104), sunset yellow (E110), white beeswax, carnauba wax and shellac.

Marketing Authorisation Holder: Ranbaxy (UK) Limited, Building 4, Chiswick Park, 566 Chiswick High Road, London, W4 5YE, United Kingdom.

Manufacturer: Custom Pharmaceuticals Limited, Conway Street, Hove, East Sussex, BN3 3LW.

1. What Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets are and what they are used for

Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets are used as an adjunct in the management of conditions such as chronic obstructive pulmonary disease (COPD), when characterised by thick viscid or glutinous mucus, including the symptomatic relief of cough with sputum.

Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets are round, biconvex, yellow, sugar-coated tablets available in a pack size of 100 tablets.

Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets are used together with other medicines to help in the treatment of conditions in which thick mucus is a problem e.g. sinusitis (inflamed nasal tubes), secretory otitis media (discharge from the middle ear) and in the symptomatic relief of cough with sputum.

2. Before you take Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets

Do not take Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets and speak to your doctor or pharmacist if any of the following apply to you:

•    You have previously had an allergic reaction to mecysteine, carbocysteine or N-acetylcysteine or to any of the tablet ingredients listed above.

Talk to your doctor or pharmacist before taking this medicine if any of the following apply to you:

•    You are pregnant, or planning to become pregnant, or are breast feeding. Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking this medicine.

Important information about some of the ingredients of Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets

Your medicine contains lactose and sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Your medicine contains sunset yellow (E110) which may cause allergic reactions.

3. How to take Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets

Take your medicine as instructed by your doctor. Do not take more than the doctor told you. Check the label carefully for how much to take and how often to take it. Your pharmacist or doctor can help if you are not sure.

For Adults and the Elderly: 1-2 tablets three to four times daily before meals with a little water. A rapid clinical effect can be achieved by giving 2 tablets 4 times daily for the first 2 days of therapy.

The standard dose, 2 tablets 3 times a day, is given for 6 weeks and thereafter, the dose should be reduced to 2 tablets twice daily.

For Children over 5 years: One tablet three times daily.

For Children under 5 years: Not recommended.

Swallow the tablets just as they are with a glass of water. Do not crush or chew the tablets as they are enteric coated.

If you take too many Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets

If you have taken more Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets than you should, consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet with you so your doctor will know what you have taken.

If you forget to take your Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets

If you forget to take Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets at the right time, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.

4.    Possible side effects

Please tell your doctor or pharmacist if you are getting any untoward effects.

5.    Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets

Do not store above 25°C.

Keep out of the reach and sight of children.

Do not take after the expiry date on the labelling.

This leaflet was last revised in October 2013.